FDA to Review Extended-Release Formulation of Lorcaserin
Eisai and Arena announced that the Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for extended-release lorcaserin as once daily dosing option for chronic weight management.
The NDA acceptance for the extended-release formulation is based on results of two Phase 1 registrational clinical trials evaluating bioequivalence of a once daily, 20mg extended-release lorcaserin compared to the currently approved, twice daily 10mg immediate-release formulation. If approved, the extended-release formulation is expected to be marketed as Belviq XR.
Immediate-release lorcaserin, marketed as Belviq, is currently approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30kg/m2 or ≥27kg/m2 in the presence of at least one weight-related comorbidity (eg, hypertension, dyslipidemia, type 2 diabetes mellitus).
Lorcaserin is a serotonin 2C receptor agonist.
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